Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

NCT ID: NCT05405842

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-09-30

Brief Summary

The goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS.

Detailed Description

This is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastroparesis and functional dyspepsia patients. The investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. Participants will undergo two testing sessions in which electrogastrography (EGG) and heart rate variability (HRV) will be measured using electrodes following transauricular vagal nerve stimulation (tAVNS) at various frequencies.

Conditions

Gastroparesis; Functional Dyspepsia; Healthy; Digestive System Disease; Gastroenterology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gastroparesis

Patients diagnosed with Gastroparesis.

Group Type: EXPERIMENTAL

Transauricular Vagal Nerve Stimulation

Intervention Type: DEVICE

TENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison.

Functional Dsypepsia

Patients diagnosed with Functional Dsypepsia.

Group Type: EXPERIMENTAL

Transauricular Vagal Nerve Stimulation

Intervention Type: DEVICE

TENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison.

Healthy Controls

Healthy volunteers (without Functional Dsypepsia or Gastroparesis)

Group Type: EXPERIMENTAL

Transauricular Vagal Nerve Stimulation

Intervention Type: DEVICE

TENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison.

Interventions

Transauricular Vagal Nerve Stimulation

TENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison.

Intervention Type: DEVICE

Other Intervention Names

vagal nerve stimulation

Eligibility Criteria

Inclusion Criteria

1. Male or female.

2. Age 18-85 years.

3. Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia.

4. Patient is capable of giving informed consent.

5. Patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).

Exclusion Criteria

1. Any diagnosis of systemic autonomic dysfunction.

2. Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study.

3. Enteric feeding tubes.

4. Parenteral nutrition.

5. Severe disease flare requiring hospitalization or ER visits within 3 months of study.

6. Untreated depression or suicidal thoughts.

7. Pregnant/breastfeeding women.

8. History of gastric pacemaker implantation.

9. Implantable electronic devices (i.e. cardiac pacemakers)

10. Extrinsic myopathy/neuropathy

11. Vagal nerve injury.

12. High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter).

13. GERD.

14. History of dumping syndrome.

15. History of rapid gastric emptying.

16. Severe allergy to skin adhesives.

17. Concurrent enrollment in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Linda Nguyen

Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy XY Zhou, DO

Role: STUDY_DIRECTOR

Fellow

Sandya Subramanian, Phd

Role: PRINCIPAL_INVESTIGATOR

Postdoctoral Fellow

Todd Coleman, Phd

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Linda Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Professor of Medicine

Other Identifiers

63421

Identifier Type: -

Identifier Source: org_study_id